|
Device | Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P120002 |
Supplement Number | S018 |
Date Received | 09/25/2020 |
Decision Date | 10/23/2020 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replace a supplier's winding equipment used to manufacture a component of the delivery system. |